FDA Issues Three Warning Letters on Contaminated Eye Drops

The FDA has issued warning letters to three eye drop manufacturers as part of ongoing investigations into a multi-state outbreak of more than 80 antibiotic-resistant eye infections that have led to four patient deaths and at least 14 cases of vision loss.

In February 2023, the FDA warned consumers and health care practitioners not to purchase and to immediately stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears after a manufacturing inspection exposed the potential of bacterial contamination.

The letter to Delsam, a company based in Mamaroneck, N.Y., says that it contracts with Global Pharma Healthcare Private Limited, a UK-based contract manufacturer, for its products. The agency said that it found that Delsam received a shipment of products in February 2021 and “distributed products in this shipment that were found to be not sterile by FDA testing.”

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